Bioniche Announces Q1/2015 Timeline for the Filing of a Biologics License Application for Marketing Approval of MCNA in the United States
BELLEVILLE, ON, Aug. 19, 2014 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) today announced that it is targeting Q1/2015 for the filing of a Biologics License Application (BLA) with the United States Food and Drug Administration (FDA) for Bioniche's lead program Mycobacterial Cell Wall-Nucleic Acid Complex (MCNA) for the treatment of patients with high grade non-muscle invasive bladder cancer that have failed Bacillus Calmette-Guérin (BCG) therapy. This projected timeline integrates the conclusions of a regulatory gap analysis prepared by its consultants (reviewing the state of each BLA module and estimating the time to complete) with the planning and scheduling of a pre-BLA meeting between Bioniche and the FDA prior to the BLA filing.
Reporting on this analysis, Dr. Michael Berendt, Bioniche's CEO & Chief Scientist, stated that: "Based on this preliminary, but thorough analysis, we expect to be able to file a BLA for MCNA in the first quarter of 2015. Prior to beginning this gap analysis, I had asked both our regulatory consultants and clinical staff to forecast an aggressive, but achievable timeline. Our goal will be to try to improve on this timeline wherever possible and to ensure that our BLA filing is comprehensive and meets all FDA requirements. Given the importance of this filing to all of our stakeholders, especially to bladder cancer patients who lack a non-surgical treatment alternative, we will provide updates as we move closer to this significant regulatory milestone.
Bioniche has implemented a structured partnering process for MCNA. As part of this process, Bioniche is signing confidentiality agreements with multiple potential commercial partners wishing to conduct due diligence and to review the complete MCNA data package, available via our electronic data room. In parallel, Bioniche is engaging a third party expert consulting group to complete an independent market research and pricing/market access assessment to validate its internal estimates, and to provide a robust U.S. sales forecast and product valuation. This external commercial assessment will be key in supporting the Company through various strategic decisions, including optimizing partnering negotiations and financial terms.
MCNA Brand Name
Bioniche has previously registered and used Urocidin as the trade name for its bladder cancer drug. Recent guidance issued by the U.S. FDA related to proprietary naming regulations and requirements have made this name ineligible for use in the Unites States. As such, the company is now referring to the drug as MCNA and will be registering a new trade name as it files the BLA for MCNA.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a clinical stage Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary and innovative therapies for the global human health market. The Company's primary goal is to develop and commercialize products that advance human health and increase shareholder value. For more information, please visit www.Bioniche.com.
Except for historical information, this news release may contain forward-looking statements that reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.
SOURCE Bioniche Life Sciences Inc.